Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Final Rule for Regulating Lab-Developed Tests as Medical Devices

The Food and Drug Administration (FDA) announced on April 29, 2024 that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices. C21 has long been concerned that applying FDA regulatory requirements designed for distributed medical devices to laboratory procedures will hinder patient access to critical LDTs that are the leading edge of advancing precision medicine in patient care.

Notwithstanding certain modifications as compared to the proposed rule, C21 is concerned that the Final Rule will place significant additional regulatory burden on clinical laboratories that already comply with comprehensive regulations under the Clinical Laboratory Improvement Amendments (CLIA), state clinical laboratory laws, as well as evidence-based requirements of public and private payers.

C21 remains committed to working with Congress, FDA, and other stakeholders on legislation to establish a new regulatory framework to diagnostics.

About C21

The Coalition was formed in 2006 with the mission of working with the FDA to develop the appropriate regulatory pathway for advanced diagnostic tests that promote innovation and protect public health. We represent the world’s most innovative diagnostic technology companies, clinical laboratories researchers, physicians, and venture capitalists — all linked by a common mission: to develop and commercialize state of the art diagnostics that improve patient health.

The Coalition acknowledges that some groups have questioned whether FDA currently has the authority under the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) to regulate LDTs as medical devices, including the subset of LDTs that FDA sought to define for discussion in draft FDA guidance as In Vitro Multivariate Index Assays (IVDMIAs). Consistent with the approach that the Coalition has taken throughout consideration of this issue, the Coalition’s comments supportive of certain approaches to regulation should not be considered an acknowledgement by the Coalition or any of its members that FDA currently has the authority to regulate laboratory services as medical devices. In addition, these comments do not represent an admission by the Coalition or any of its members that any particular laboratory service is a “device” as that term is currently defined under Section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321(h)).

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